Impact of Severe and Very Early Onset Intra-uterine Growth Restriction on Neurodevelopemental Outcome in Preterm Infants at 2 Years Old: a Monocentric Case Control Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 主要终点
- Neurodevelopmental outcomes at 2 years old evaluated by ASQ scale
研究概览
简要总结
Very early onset intra uterine growth restriction (IUGR) affects 5-10% of pregnancies and is the second leading cause of perinatal mortality.
However, there is few studies on this subject, especially concerning the neurodevelopment outcomes.
Objective: to compare neurodevelopmental outcomes at the age of 2 of very preterm infants with antenatal duagnosis of severe and early IUGR in comparison with infants of the same gestational age, same sex and over the same period with no IUGR.
Hypothesis : Preterm infants with early and severe antenatal IUGR have more neurodevelopmental delay than infants with no IUGR.
详细描述
Method: A monocentric retrospective case control study will be conducted at the Nancy University Hospital.
Each infant included (cases) will be match to 2 controls based on gestational age, period and sex which will allow us to individualize the impact of early and severe IUGR.
Inclusion criteria: Infants born before 34 weeks of gestational age, and whose antenatal files were discussed at the pluridisciplinary antenatal diagnosis center of Nancy from 2010 to 2020 with diagnosis of IUGR confirmed between 22 and 25 years of age. IUGR is defined by estimated fetal weight inferior to the 3rd percentile for the gestational age (calculated by the Hadlok formula and reported on the CFEF curves).
Exclusion criteria: Infants with anoxo ischemic encephalopathy or major neonatal surgery.
Cases and controls have a particular follow up thanks to the "Rafael" network which is a regional perinatal network following up preterm infants and infants at risk to have impairment in neurodevelopmental outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Days 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born before 34 weeks of gestational age, and whose antenatal files were discussed at the pluridisciplinary antenatal diagnosis center of Nancy from 2010 to 2020 with diagnosis of IUGR confirmed between 22 and 25 years of age. IUGR is defined by estimated fetal weight inferior to the 3rd percentile for the gestational age (Audipog curves).
- •Each infant included will be matched to 2 controls on gestational age, period and sex
排除标准
- 未提供
结局指标
主要结局
Neurodevelopmental outcomes at 2 years old evaluated by ASQ scale
时间窗: at 2 years old
This neurodeveloppemental follow up is based on the ASQ scale witch explores 5 areas : communication, gross motor, fine motor, problem solving and personal social.
次要结局
未报告次要终点
研究者
Apolline WITTWER, MD
Praticien Hospitalier
Central Hospital, Nancy, France